COAT-A-COUNT MORPHINE KIT & COMPONENTS
Device Facts
| Record ID | K823680 |
|---|---|
| Device Name | COAT-A-COUNT MORPHINE KIT & COMPONENTS |
| Applicant | Diagnostic Products Corp. |
| Product Code | DDE · Immunology |
| Decision Date | Jan 5, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A carbonic anhydrase B and C immunological test system is a device that consists of the reagents used to measure by immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.
